The most expensive decision in drug development (or product experimentation) is not starting a trial. It is continuing a zombie trial. Imagine you are at the interim analysis of a Phase II study. You have enrolled 50 of 100 patients. You have spent $10 million. The data is... underwhelming. The
Everyone says they want adaptive designs. Almost no one actually runs them. In decks, protocols, and FDA briefing books, “adaptive” has become a fashionable adjective—usually meaning a trial with one interim look, a conditional power calculation, and a long list of things you are not allowed to change. The
In the late 1980s, cardiologists thought they had cracked the code. They knew that patients who developed irregular heartbeats, premature ventricular contractions (PVCs), after a heart attack were more likely to die. They had drugs, encainide and flecainide, that reliably suppressed those irregular beats. The intuition was flawless: Suppress the
